以高可信医疗物联网架构与全自主智能警戒，筑牢智慧医疗患者生命安全防线

HealthVigilance 深度融合床旁多参数生理体征信号实时采集、微隔离医院网络安全边界及形式化验证代码管道，彻底杜绝针对临床医疗系统的网络安全威胁与合规风险。

HealthVigilance Clinical IoMT Architecture

End-to-End Biosignal Ingestion, SaMD Logic, and Regulatory Surveillance

Central System: Clinical Vigilance Core - IEC 62304 / Zero-Trust Engine

Clinical IoMT Nodes

  • Multi-Lead Biosensors
  • FHIR R4 Gateway
  • SaMD Inference Core
  • Adverse Event Engine
  • EHR Interconnect

Architectural Layers & Regulatory Standards

  • Physical Biosignal Acquisition (IEEE 11073-10406 / BLE 5.3 Medical Coded PHY): Continuous telemetry from multi-lead ECG, PPG, and SpO2 sensors with hardware root-of-trust authentication.
  • Transport & Cryptographic Boundary (HL7 FHIR Release 4 / mTLS RFC 8446 / DICOMweb): Mutual TLS microsegmentation and FHIR REST JSON-LD data streaming across hospital boundaries.
  • SaMD Algorithmic Execution (IEC 62304 Class C / ISO 14971 Risk Engine): Deterministic bedside inference, arrhythmia detection, and hemodynamics modeling verified under IEC 62304 Class C.
  • Continuous Post-Market Vigilance (FDA 21 CFR Part 803 / EU MDR Article 87 EUDAMED): Automated anomaly ingestion, drift detection, and electronic FDA 21 CFR 803 / EU MDR adverse event dispatch.

Key Metrics: < 5 ms (Bedside Telemetry Jitter) | 99.999% (High-Assurance Uptime) | Class C (IEC 62304 Software Safety Level) | Zero-Trust (Hospital Boundary Security Model)

零信任生物信号采集与监管上市后警戒

Modern healthcare infrastructure is vulnerable to ransomware and unvalidated SaMD logic. HealthVigilance establishes cryptographic integrity across the entire patient data continuum, pairing IEEE 11073 device profiles with automated FDA 21 CFR 803 incident reporting.

Core Engineering Areas

Technical Articles

Related Cluster Architecture Specifications